BEUDAMED
    FDA Adverse Event Other Summary report: N

    NA

    MDR report key: 1028456 · Received April 11, 2008

    Report

    Report Number
    2523676-2008-00018
    Event Type
    Other
    Date Received
    April 11, 2008
    Date of Event
    March 10, 2008
    Report Date
    April 3, 2008
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FPA
    PMA / PMN Number
    K790062
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICES IN THE REPORTED INCIDENTS WERE DISCARDED AND NOT MADE AVAILABLE TO THE MANUFACTURER TO BE EVALUATED. HOWEVER, ONE REP B BRAUN VALVE WITH THE FEMALE END ATTACHED TO A MALE SPINLOCK ADAPTER OF AN ALARIS IV SET AND THE MALE LUER ATTACHED TO A B-D INTERLINK THREADED LOCK CANNULA WAS RETURNED FOR EVALUATION ALONG WITH 2 REP UNUSED B BRAUN VALVES SEALED IN THE PACKAGE IDENTIFYING THE REPORTED LOT NUMBER. THE LUER TAPERS ON THE BACKCHECK VALVES WERE TESTED TO ISO 594/1, 594/2 STANDARDS USING PLUG AND BUTTON GAUGES AND FOUND TO BE ACCEPTABLE. THE MALE LUER OF THE ADAPTER ON THE ALARIS SET WAS TESTED TO ISO 594 STANDARDS USING THE BUTTON GAGE, AND WAS FOUND ACCEPTABLE, HOWEVER, IT MEASURED ON HIGHEST SIDE OF THE GAGE. THE B BRAUN BACKCHECK VALVES WERE PHYSICALLY TESTED FOR LEAKAGE AND SUBJECTED TO A PRESSURE TEST PER SPECIFICATION. THE SAMPLE PASSED AND NO LEAKS WERE NOTED. THE RETURNED BACKCHECK VALVES WERE ATTACHED TO THE MALE FITTING ON THE ALARIS SET AND ALL CONNECTIONS WERE NOTED TO BE TIGHT AND SECURE. THERE WAS NO LEAKAGE NOTED FROM EITHER OF THE VALVES OR AT THE CONNECTIONS WHILE APPLYING EIGHT PSI PNEUMATIC PRESSURE. HOWEVER, WITH SLIGHT MANIPULATION THE SPINLOCK COLLAR ON THE ALARIS MALE ADAPTER BECAME LOOSE. NO SPECIFIC CONCLUSIONS CAN BE DRAWN. HOWEVER, THESE INCIDENTS APPEAR TO BE RELATED TO MULTIPLE LUER CONNECTIONS BEING USED IN COMBINATION WITH THE ALARIS SETS MALE ADAPTER WHICH DOES NOT APPEAR TO BE CENTERED ON THE ISO 594 REQUIREMENT GAUGE. ADD'L LOT NUMBER: 60966552. ADD'L EXPIRATION DATE: 12/31/2012. ADD'L DEVICE MANUFACTURER DATE: 02/2008.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY, PT WAS 25 MINUTES INTO A 30 MIN CHEMOTHERAPY INFUSION; PT NOTICED A TEAR DROP STAIN ON HIS SHIRT. THE INFUSION WAS PAUSED, CONNECTION CHECKED, NO LEAKAGE OBSERVED, INFUSION RESUMED. AT THE END OF THE INFUSION, A TEAR DROP WAS OBSERVED AT THE PROXIMAL END OF THE BC1000. INFUSION DISCONTINUED AS WELL AS REMOVING THE LINE. ADD'L INFO PROVIDED BY THE USER FACILITY INDICATED A SECOND INCIDENT INVOLVING A SMALL AMOUNT OF CHEMO DRUG ALSO LEAKED AT THE CHECK VALVE CONNECTION TO THE PRIMARY TUBING. THE PTS SUFFERED NO ADVERSE SEQUELA ASSOCIATED WITH THE INCIDENTS. THE ROUTINE CONNECTION WITH THE B BRAUN VALVE IS THE ALARIS PRIMARY IV SET TO THE B BRAUN VALVE TO THE B-D THREADED LOCK CANNULA TO THE INTERLINK CONNECTOR TO AN IV CATHETER PORT. THE STAFF IS CHECKING THE CONNECTIONS AT LEAST ONCE OR TWICE A SHIFT, HOWEVER, THERE IS "A LOT OF TWISTING AND TURNING" OCCURRING WITH FOUR CONNECTIONS ON THIS SET UP. THE FACILITY MADE THE DECISION TO USE THE B BRAUN BACKCHECK VALVE AS FREE PROTECTION DUE TO A DEFECT IN THE ALARIS PUMP'S FREE FLOW PROTECTION FUNCTION. ADD'L INFO ALSO INDICATED THE DECISION TO USE THE B BRAUN VALVE WAS STARTED IN THE FACILITY WITHOUT CONSULTATION WITH A B BRAUN REP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA BACKCHECK VALVE ASSEMBLY FPA B. BRAUN MEDICAL, INC. BC-1000 60961172

    Patients

    Seq Age Sex Outcome Treatment
    1 Other